Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT00075959
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2004-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D002385', 'term': 'Cataplexy'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C120851', 'term': 'disufenton sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2004-01-12', 'studyFirstSubmitQcDate': '2004-01-13', 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global disability on modified Rankin scale at 90 days'}], 'secondaryOutcomes': [{'measure': 'NIH stroke scale'}, {'measure': 'Barthel Index'}, {'measure': 'Stroke Impact Scale'}]}, 'conditionsModule': {'keywords': ['Stroke', 'cerebral vascular accident', 'CVA', 'Hemorrhage', 'Intracerebral Hemorrhage (ICH)', 'Brain Attack', 'Cataplexy'], 'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Intracerebral Hemorrhage as the cause of stroke symptoms\n* Onset of symptoms within 6 hours\n* Full functional independence prior to the present stroke\n\nExclusion Criteria:\n\n* Unconsciousness\n* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.\n* Severe illness with life expectancy less than 6 months.\n* Known severe kidney disorder.\n* Current known alcohol or illicit drug abuse or dependence.\n* Pregnant or breast-feeding.\n* Treatment with acetazolamide and methotrexate is not permitted during the infusion\n* Participation in a previous clinical study within 7 days.\n* Meets all other exclusion criteria'}, 'identificationModule': {'nctId': 'NCT00075959', 'briefTitle': 'Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'CHANT (Cerebral Hemorrhage And NXY Treatment) A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Phase IIb Study to Assess the Safety and Tolerability of Intravenous Infusion of NXY-059 in Adult Patients With Acute Intracerebral Hemorrhage (ICH)', 'orgStudyIdInfo': {'id': 'SA-NXY-0012'}, 'secondaryIdInfos': [{'id': '0012'}, {'id': 'CHANT'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'NXY-059', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.44047, 'lon': 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'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'city': 'Schenectady', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.81424, 'lon': -73.93957}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': 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